Health News Roundup: US FDA approves Genmab-AbbVie's blood cancer therapy; WHO recommends new COVID shots should target only XBB variants and more
A U.S. district court judge issued a temporary restraining order late on Wednesday after the two companies and the FTC reached an agreement that both sides said in a joint filing would permit a full briefing and "less-compressed consideration" by the court of the FTC request. U.S. FDA approves Krystal Biotech's skin-disorder gene therapy The U.S. Food and Drug Administration on Friday approved Krystal Biotech Inc's first-of-its kind topical gene therapy for patients with a genetic skin disorder, sending its shares up 7% in afternoon trading.
Following is a summary of current health news briefs.
CureVac files expanded patent lawsuit against Pfizer/BioNTech over mRNA technology
CureVac NV said on Friday it had filed an expanded patent infringement claim against Pfizer Inc and BioNTech over the use of mRNA technology and that a U.S. court had granted its request to transfer the trial. The company said it filed a counterclaim alleging that Pfizer and its German partner BioNTech infringed on nine of its patents, broader than its original claim of three patents.
Brazil investigates four more suspect cases of avian flu in wild birds
Brazil is investigating another four new potential cases of highly pathogenic avian influenza (H5N1) in wild birds, according to authorities from the state of Espirito Santo, where Brazil's first ever cases were confirmed this week. After the birds showed symptoms consistent with H5N1, samples were taken from the four, all of them from the Thalasseus acuflavidus species (Cabot's terns), according to a statement from Espirito Santo's Agriculture, Supply, Aquaculture and Fisheries agency on Friday.
AstraZeneca will seek to "love the Communist Party" - China boss
Global drugmaker AstraZeneca will seek to be a patriotic company in China that "loves the Communist Party", its China president said on Friday. Wang Lei, who is also the company's global executive vice president, made the comment at an event in the eastern city of Wuxi to celebrate the drugmaker's 30th year in China, according to a person familiar with the matter.
US FDA approves Genmab-AbbVie's blood cancer therapy
The U.S. Food and Drug Administration has approved AbbVie Inc and Danish drugmaker Genmab's blood cancer therapy for adult patients who have received at least two prior lines of treatment, the companies said on Friday. The drug, epcoritamab, to be sold under the brand name Epkinly was developed to treat a type of advanced large B-cell lymphoma, a cancer that starts in white blood cells.
US FDA panel votes against accelerated approval of Intercept fatty liver drug
A panel of advisers to the U.S. Food and Drug Administration on Friday recommended holding off on an accelerated approval of Intercept Pharmaceuticals Inc's oral drug for a type of fatty liver disease until more study data is available. The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring, of the liver.
London court throws out lawsuit against Google over medical records
Google on Friday defeated a lawsuit brought on behalf of 1.6 million people over medical records provided to the U.S. tech giant by a British hospital trust. The Royal Free London NHS Trust transferred patient data to Google's artificial intelligence firm DeepMind Technologies in 2015 in relation to the development of a mobile app designed to analyse medical records and detect acute kidney injuries.
WHO recommends new COVID shots should target only XBB variants
A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants. New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.
Catalent cuts forecast, delays results again as challenges mount
Contract drug manufacturer Catalent Inc on Friday slashed its full-year forecasts for profit and sales and delayed its quarterly results for the third time, bruised by a series of missteps at its major production facilities. The company promised to take steps to correct the issues and said it had changed the financial directors at facilities with the greatest challenges, besides naming a new interim chief financial officer last month.
Amgen agrees not to seek quick close to Horizon acquisition
Amgen Inc has agreed not to quickly close on its $27.8 billion acquisition of Horizon Therapeutics after the U.S. Federal Trade Commission (FTC) filed suit to block the deal. A U.S. district court judge issued a temporary restraining order late on Wednesday after the two companies and the FTC reached an agreement that both sides said in a joint filing would permit a full briefing and "less-compressed consideration" by the court of the FTC request.
U.S. FDA approves Krystal Biotech's skin-disorder gene therapy
The U.S. Food and Drug Administration on Friday approved Krystal Biotech Inc's first-of-its kind topical gene therapy for patients with a genetic skin disorder, sending its shares up 7% in afternoon trading. Patients with the rare dystrophic epidermolysis bullosa disorder suffer from open wounds, causing skin infections and are at an increased risk of vision loss, scarring and skin cancer. Most patients rarely survive beyond 30 years of age.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)